• Review and approvals of Change controls, Deviations, CAPA, Quality Risk assessment and Drug Product Complaints.• Review and approval of QAMS trends (Change controls, deviations, CAPA and Quality Risk assessment).• Preparation and review of Gap assessment reports for regulatory guidelines and inter units audit observations.• Investigation of Drug Product Complaints, Deviations and non-conforming product and proposing the appropriate CAPA’s.• Scheduling and executing self-inspection plan and taking part in Customer / Regulatory inspections.• Preparation and review of audit compliance report to the internal and external audits• Preparation and review of Batch manufacturing records, Batch Packaging records.• Preparation and review of Site Master File, Quality Manual, Quality Assurance and other departmental SOP and implementation of respective procedures. • Sampling of raw materials, packaging materials, in-process samples and finished product samples.• Sampling of Cleaning validation samples, in process samples, finished product and submission to QC for testing.• Review and approval of equipment qualification protocols (DQ / IQ / OQ / PQ). • Qualification of vendors for Raw materials.• Preparation and review of Process Validation, Cleaning Validation and Hold time study protocols and reports.• Preparation and Review of APQR and its quality trends.• Conducting and co-ordination of cGMP training for all employees on annual basis and updating the respective employees training documents.• Review of Analytical validation protocols and reports.• Review of analytical validation data against the chromatograms and analytical notebook.• Preparation and review of stability compilation data and stability reports for exhibit and Validation batches.• Maintenance of documentation cell and issuance / retrieval of documents from the other departments.

• Review and approvals of Supplier defects.• Evaluation and Qualification of suppliers of RM (Raw Material) and PM (Packing Material).• Planning and Performing 2nd party audit on component suppliers for API and Formulations:• Investigations and review of spikes in the quality trends of the APQR.• Handling of breach of Data integrity issues.• Review of Technology transfer documents received from R&D site for the execution of Exhibit batches for regulatory Submission.• Preparation and presentation of Quality Review meeting on monthly basis to the top management.• Preparation and review of Analytical method validation / transfer protocols and reports for newly introduced products.• Preparation and review of cleaning validation / verification protocols and reports for newly introduced products.• Review of validation reports and stability compilation data for validation batches and exhibit batches prior submitting it for ANDA filing and variation filings.• Preparation and review of audit compliance reports for Self-inspection, Regulatory and customer audits.• Conducting and co-ordination of new product meetings.• Review and approvals of Specification, STP’s for Raw materials, packing materials, In-process and finished products.• Conducting the cGMP trainings, awareness programs on error reductions for manufacturing and analytical associates.

• Qualification of QAMS software in the site in coordination with the CQA team and vendor.• Review and implementation of Artwork design (Carton, leaflet, tubes, Foils) for packing materials at the plant level.• Qualification and validation of Caliber QAMS software.• Investigation of Spikes in the annual product quality review.• Preparation and review of Quality Risk Assessment and participation in the FMEA sessions.• Preparation and review of audit compliance repoxrts for Internal Audit / Customer audits.

• Preparation, Review and approvals of Specification, STP’s for Raw materials, packing materials, In-process and finished products. • Preparation of General testing procedures as per the USP and EP monographs for Quality Control Laboratory. • Daily inspection of Quality control laboratory. • Review and lab release of finished product, in-process samples and Raw materials.• Preparation, Review and approval of Analytical data sheets for finished products and raw materials.• Preparation of calibration and preventive maintenance schedules for all QC instruments.

• Analysis of Finished product, in-process samples and raw materials as per the approved testing methods. • Sampling of Raw materials and packaging materials. • Calibration of HPLC, Dissolution apparatus, UV and IR spectrophotometers and KF autotitrator. • Standardization of volumetric solutions at regular intervals to determine the validity. • Maintenance and reconciliation of USP reference standard.• Loading of stability samples into the stability chambers and withdrawing the samples as per the stability schedule.• Preparation of general testing procedure as per USP general chapters.• Preparation and Quality control operating procedures.• Maintenance and issuance of analytical notebooks.• Daily calibrations of Balances, pH meter and Conductivity meter. • Determining the water content for KF apparatus. • Verification of column performance for new HPLC columns.• Handling of entire QC related transactions in Caliber LIMS.